Job-ID Reference Responsibilities: Lead clinical data management activities for pivotal trials, ensuring data quality and integrity Collaborate with cross-functional teams to support clinical trial data management processes Oversee vendor management and ensure compliance with regulatory standards Drive development and implementation of data management plans and validation activities Coordinate data cleaning and reporting activities to meet project goals Support database design, validation, and maintenance for clinical trials Ensure adherence to Good Clinical Practice (GCP) and regulatory requirements Provide leadership and guidance to data management teams and stakeholders Act as Data Management Study Lead for multiple clinical trials Manage vendor relationships and ensure timely delivery of data management services Develop and maintain critical data management documentation and plans Coordinate data transfer setups and validations, ensuring consistency with agreements Perform supplemental data reviews and quality checks as per validation specifications Participate in study document reviews, including protocols and statistical analysis plans Ensure compliance with CDISC standards and clinical research regulations Report project status and escalate study-related issues to senior leadership Requirements: Bachelor of Science degree with 10+ years of clinical data management experience Proficiency in EDC systems, CDISC standards, and clinical research regulations Experience managing multiple CROs/vendors and ensuring data quality Strong knowledge of database structures and data visualization technologies Excellent interpersonal, organizational, and communication skills Ability to prioritize tasks and work effectively in a fast-paced environment Logical thinking and attention to detail for high-quality data management Commitment to maintaining compliance with GCP and regulatory standards.
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